125742 S1 M5 CRF c4591001 1168 11681225

Document text

Page 1 of 187
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814695
Page 2 of 187
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/8/2020
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814696
Page 3 of 187
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11681225]
2.Birth Date: /1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814697
Page 4 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814698
Page 5 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814699
Page 6 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814700
Page 7 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814701
Page 8 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814702
Page 9 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
2.Weight: [75.2]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [26.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814703
Page 10 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814704
Page 11 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/8/2020
2.Randomization Number: [268062]
3.Randomization Group: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814705
Page 12 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY7PB]
5.bSample ID [BPY7PC]
5.cSample ID [BPY7PD]
5.dSample ID [BRTRF1]
5.eSample ID [BRTRF2]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814706
Page 13 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY7P8]
5.bSample ID [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814707
Page 14 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/8/2020 16:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814708
Page 15 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814709
Page 16 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814710
Page 17 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814711
Page 18 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814712
Page 19 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8SX4]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814713
Page 20 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/29/2020 15:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814714
Page 21 of 187
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814715
Page 22 of 187
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8SZ8]
5.bSample ID [BNW8KP]
5.cSample ID [BNW8KR]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814716
Page 23 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814717
Page 24 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814718
Page 25 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814719
Page 26 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814720
Page 27 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814721
Page 28 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814722
Page 29 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814723
Page 30 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814724
Page 31 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814725
Page 32 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814726
Page 33 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  SWOLLEN LYMPH
NODES Feb/1/2021 UNK:
UNK NO
End Date Time:
Feb/4/2021 UNK:UNK
 Repeating
Pages
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814727
Page 34 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[SWOLLEN LYMPH NODES]
4.Start Date Time: Feb/1/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/4/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814728
Page 35 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814729
Page 36 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814730
Page 37 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814731
Page 38 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814732
Page 39 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814733
Page 40 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814734
Page 41 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814735
Page 42 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814736
Page 43 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814737
Page 44 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814738
Page 45 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814739
Page 46 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814740
Page 47 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814741
Page 48 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814742
Page 49 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814743
Page 50 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814744
Page 51 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814745
Page 52 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814746
Page 53 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814747
Page 54 of 187
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Nov/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814748
Page 55 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814749
Page 56 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814750
Page 57 of 187
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814751
Page 58 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814752
Page 59 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/7/2021
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814753
Page 60 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814754
Page 61 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Jan/7/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814755
Page 62 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814756
Page 63 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8T3N]
5.bSample ID [BRTRMY]
5.cSample ID [BRTRMZ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814757
Page 64 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8T3M]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814758
Page 65 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/7/2021 10:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814759
Page 66 of 187
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814760
Page 67 of 187
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814761
Page 68 of 187
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814762
Page 69 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814763
Page 70 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814764
Page 71 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8T89]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814765
Page 72 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 10:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814766
Page 73 of 187
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814767
Page 74 of 187
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/3/2021
3.Comments: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814768
Page 75 of 187
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814769
Page 76 of 187
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814770
Page 77 of 187
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814771
Page 78 of 187
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814772
Page 79 of 187
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Mar/3/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814773
Page 80 of 187
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/30/2020
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814774
Page 81 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814775
Page 82 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814776
Page 83 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-12-2020 09:15:02 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814777
Page 84 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-12-2020 09:19:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814778
Page 85 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814779
Page 86 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814780
Page 87 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814781
Page 88 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814782
Page 89 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814783
Page 90 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814784
Page 91 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814785
Page 92 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-12-2020 09:19:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814786
Page 93 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 07:35:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814787
Page 94 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814788
Page 95 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814789
Page 96 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814790
Page 97 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814791
Page 98 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814792
Page 99 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814793
Page 100 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814794
Page 101 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-30-2020 07:35:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814795
Page 102 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-07-2021 14:53:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814796
Page 103 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-07-2021 14:55:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814797
Page 104 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814798
Page 105 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814799
Page 106 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814800
Page 107 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Jan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814801
Page 108 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Jan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814802
Page 109 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814803
Page 110 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814804
Page 111 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-07-2021 14:55:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814805
Page 112 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-28-2021 11:51:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814806
Page 113 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814807
Page 114 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814808
Page 115 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814809
Page 116 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Jan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814810
Page 117 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Jan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814811
Page 118 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814812
Page 119 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814813
Page 120 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-28-2021 11:51:33 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814814
Page 121 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-28-2021 11:51:03 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven Cox  Approved Jan-26-2021 09:23:05 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenCox, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-30-2020 11:07:45 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven Cox  Approved Nov-11-2020 15:17:58 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenCox, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814815
Page 122 of 187
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-12-2020 09:13:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-12-2020 09:13:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814816
Page 123 of 187
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-12-2020 09:13:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/8/2020Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814817
Page 124 of 187
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-12-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11681225Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-12-2020 09:12:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-12-2020 09:14:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-12-2020 09:14:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-12-2020 09:14:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AMERICAN INDIAN OR ALASK
A NATIVEInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814818
Page 125 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020 09:14:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814819
Page 126 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-12-2020 09:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 09:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020 09:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814820
Page 127 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Oct-12-2020 09:17:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:HYSTERECTO
MY
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/
2000Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-12-2020 09:17:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-12-2020 09:17:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYSTERECTOMYInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-12-2020 09:17:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814821
Page 128 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-12-2020 09:17:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814822
Page 129 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-12-2020 09:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814823
Page 130 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
75.2Initial Entry
3. Unit:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.6Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814824
Page 131 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-12-2020 09:18:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814825
Page 132 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814826
Page 133 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-12-2020 09:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814827
Page 134 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-12-2020 09:19:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-12-2020 09:19:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
268062Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814828
Page 135 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 09:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 09:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 09:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 09:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-12-2020 09:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 09:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY7PBInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814829
Page 136 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 09:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY7PBInitial Entry
5.b
Date Location User Value Reason
Oct-13-2020 09:28:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY7PCInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 09:28:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY7PCInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020 09:29:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY7PDInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-13-2020 09:29:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY7PDInitial Entry
5.d
Date Location User Value Reason
Oct-13-2020 09:29:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTRF1Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814830
Page 137 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Oct-13-2020 09:29:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTRF1Initial Entry
5.e
Date Location User Value Reason
Oct-13-2020 09:29:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTRF2Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-13-2020 09:29:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTRF2Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814831
Page 138 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 09:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 09:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 09:28:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-13-2020 09:27:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened There are more than
1 barcode present
for sample
collection. Please
review and correct
as appropriate.
Oct-13-2020 09:26:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 09:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-12-2020 09:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814832
Page 139 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct/8/2020
5.a
Date Location User Value Reason
Oct-13-2020 09:26:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY7P8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 09:26:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY7P8Initial Entry
5.b
Date Location User Value Reason
Oct-13-2020 09:28:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Oct-13-2020 09:27:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY7PBInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 09:28:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Oct-13-2020 09:27:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY7PBInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814833
Page 140 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020 16:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814834
Page 141 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-12-2020 09:21:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814835
Page 142 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-12-2020 09:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814836
Page 143 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 07:34:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814837
Page 144 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-30-2020 07:34:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
2.a
Date Location User Value Reason
Oct-30-2020 07:34:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-30-2020 07:34:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-30-2020 07:34:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-30-2020 07:34:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814838
Page 145 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-30-2020 07:34:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814839
Page 146 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814840
Page 147 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-30-2020 07:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814841
Page 148 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 07:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 07:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 08:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 04:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 07:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 07:35:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814842
Page 149 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-02-2020 08:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8SX4Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 08:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8SX4Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814843
Page 150 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020 15:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814844
Page 151 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-30-2020 07:36:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814845
Page 152 of 187
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-30-2020 11:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/30/2020Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814846
Page 153 of 187
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-30-2020 11:07:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-30-2020 11:07:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-30-2020 11:13:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-30-2020 11:07:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-30-2020 11:07:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/30/2020Initial Entry
5.a
Date Location User Value Reason
Nov-30-2020 11:13:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8SZ8Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814847
Page 154 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Nov-30-2020 11:13:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8SZ8Initial Entry
5.b
Date Location User Value Reason
Nov-30-2020 11:14:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW8KPInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-30-2020 11:14:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW8KPInitial Entry
5.c
Date Location User Value Reason
Nov-30-2020 11:14:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW8KRInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-30-2020 11:14:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW8KRInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814848
Page 155 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814849
Page 156 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWOLLEN LYMPH NODESInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/1/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/4/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814850
Page 157 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814851
Page 158 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-03-2021 15:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814852
Page 159 of 187
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-30-2020 11:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-30-2020 11:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-30-2020 11:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814853
Page 160 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 11:22:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Transcription Error
Jan-07-2021 14:52:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814854
Page 161 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021 09:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-07-2021 23:55:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-07-2021 14:52:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-07-2021 14:52:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814855
Page 162 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-07-2021 14:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814856
Page 163 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-07-2021 14:53:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/7/2021Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814857
Page 164 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-07-2021 14:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-07-2021 14:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-07-2021 14:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814858
Page 165 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814859
Page 166 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-07-2021 14:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814860
Page 167 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-07-2021 14:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-07-2021 14:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 16:11:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-08-2021 06:52:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-07-2021 14:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-07-2021 14:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/7/2021Initial Entry
5.a
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814861
Page 168 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-13-2021 16:11:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8T3NInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 16:11:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8T3NInitial Entry
5.b
Date Location User Value Reason
Jan-13-2021 16:11:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTRMYInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-13-2021 16:11:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTRMYInitial Entry
5.c
Date Location User Value Reason
Jan-13-2021 16:12:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTRMZInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-13-2021 16:12:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTRMZInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814862
Page 169 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-07-2021 14:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-07-2021 14:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 16:12:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-08-2021 06:52:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-07-2021 14:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-07-2021 14:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/7/2021Initial Entry
5.a
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814863
Page 170 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-13-2021 16:12:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8T3MInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 16:12:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8T3MInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814864
Page 171 of 187
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021 10:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814865
Page 172 of 187
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-07-2021 14:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814866
Page 173 of 187
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Mar-01-2021
03:46:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies
query
Feb-26-2021
11:22:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dChanged data per
query
Feb-25-2021
16:12:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedDate Treatment
Unblinded should be
equal to or after DOV
in REVAX CONTACT
visit when Reason is
ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Feb-25-2021
16:10:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
seddata updated
Feb-23-2021
21:30:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dplease unlock the dov
in revax contact so the
date can be updated to
05JAN2021
Feb-23-2021
10:50:13ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: OpDMW7352535;Date
Treatment Unblinded
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814867
Page 174 of 187
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00)
Central Time
(US &
Canada)enedshould be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Jan-12-2021
09:07:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Jan/5/
2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-12-2021 09:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814868
Page 175 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 11:51:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814869
Page 176 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814870
Page 177 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-28-2021 11:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814871
Page 178 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 11:51:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 11:51:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 15:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 11:51:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-28-2021 11:51:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-28-2021 15:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8T89Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814872
Page 179 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Jan-28-2021 15:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8T89Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814873
Page 180 of 187
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021 10:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814874
Page 181 of 187
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-28-2021 11:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814875
Page 182 of 187
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 15:33:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814876
Page 183 of 187
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-03-2021 15:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-03-2021 15:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/3/2021Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814877
Page 184 of 187
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-05-2021
00:19:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edResponse satisfies
query
Mar-04-2021
16:24:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
wereddata entered per EDC
guidelines
Mar-04-2021
01:39:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7592756;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Mar-03-2021
15:35:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Mar/3/
2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-03-2021 15:35:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814878
Page 185 of 187
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-03-2021 15:35:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0814879
Page 186 of 187
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-30-2020 11:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-12-2020 09:19:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-12-2020 09:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-30-2020 11:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/30/2020Initial Entry
Oct-12-2020 09:19:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/8/2020Initial Entry
Oct-12-2020 09:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/8/2020Initial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814880
Page 187 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681225 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-29-2020 13:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae40d0\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814881